The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.

The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.

Secondary Outcome Measures:

Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG. [ Time Frame: post operative ] [ Designated as safety issue: No ]

Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses [ Time Frame: post operative ] [ Designated as safety issue: No ]

Provide a Cost/Benefit Analysis With Regard to the Use of CBSG in Stapled Circular Anastomoses [ Time Frame: study completion ] [ Designated as safety issue: No ]

Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses. [ Time Frame: study completion ] [ Designated as safety issue: No ]

Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Procedure: Staple line without reinforcement

colorectal and coloanal anastomotic staple line without reinforcement

Detailed Description:

This is a randomized prospective trial that compares the use of GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (CBSG) to standard stapling techniques in colorectal resections. The potential exists to utilize CBSG as a means of lowering the rate of post-operative anastomotic leakage and bleeding in high-risk colorectal, coloanal, and ileoanal anastomoses.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects who will undergo restorative proctectomy or proctocolectomy (<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663819

Locations

United States, Alabama

University of South Alabama

Mobile, Alabama, United States, 36617

United States, California

University of Southern California, Keck School of Medicine

Los Angeles, California, United States, 90033

United States, Florida

University of South Florida-Cleveland Clinic Florida

Weston, Florida, United States, 33331

United States, Illinois

Advocate Healthcare/Good Shepard Hospital

Barrington, Illinois, United States, 60010

John Stroger Hospital of Cook County

Chicago, Illinois, United States, 60612

Peoria Surgical Group

Peoria, Illinois, United States, 61606

United States, Indiana

Colon and Rectal Surgery-NEICRS Group

Fort Wayne, Indiana, United States, 46845

Kenderick Regional Center

Indianapolis, Indiana, United States, 46237

United States, Michigan

Spectrum Health -Ferguson Group

Grand Rapids, Michigan, United States, 49503

United States, Minnesota

Duluth Clinic

Duluth, Minnesota, United States, 55805

United States, New York

Albany Medical College

Albany, New York, United States, 12208

St. Lukes-Roosevelt Hospital Center

New York, New York, United States, 10019

New York Presbyterian Hospital

New York, New York, United States, 10032

United States, Ohio

University Hospitals of Cleveland, Case Medical Center

Cleveland, Ohio, United States, 44106-5047

United States, Texas

Texas Endosurgery Institute

San Antonio, Texas, United States, 78222

United States, Utah

University of Utah Health Sciences Center and Huntsman Cancer Hospital